Rationale, design, and protocol for a sequential, multiple assignment, randomized trial of adaptive treatment for...

Area of Science:

• Clinical Trials
• Smoking Cessation
• Public Health

Background:

• Most smoking cessation attempts fail, even with FDA-approved medications.
• Limited research exists on optimal strategies after initial treatment failure.
• This study addresses the need for evidence-based guidance for persistent smokers.

Purpose of the Study:

• To determine if switching smoking cessation pharmacotherapies improves abstinence rates after initial failure.
• To assess if switching to e-cigarettes is more effective than continuing pharmacotherapy for smokers with successive treatment failures.
• To provide data-driven recommendations for optimizing smoking cessation outcomes.

Main Methods:

• Adult daily smokers in South Carolina and Alabama were recruited.
• Participants received a 4-week supply of combination nicotine replacement therapy or varenicline.
• Non-responders were assigned to switch medications (Aim 1) or switch to e-cigarettes (Aim 2) in a 2:1 ratio.

Main Results:

• Biochemically confirmed 7-day abstinence from smoking is the primary outcome.
• Secondary outcomes include smoking reduction, nicotine dependence, and duration of abstinence.
• Outcomes will be assessed through 6 months.

Conclusions:

• This trial will offer crucial guidance for treatment decisions following smoking cessation failure.
• Results aim to optimize cessation success for individuals struggling to quit combustible cigarettes.
• The findings will inform clinical practice and public health strategies for tobacco dependence treatment.